Glucolour

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K781308 ↗

FDA Product Code

CGE

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Urea Nitrogen Test Kit

  Class II

  FDA 510(k) K781306 Active Cleared 31 Aug 1978

• Got Procedure

  Not classified

  FDA 510(k) K781309 Active Cleared 31 Aug 1978

• Enzymatic Cholesterol (Colorimetric

  Class I

  FDA 510(k) K823784 Active Cleared 14 Jan 1983

• Direct Creatinine Procedure

  Class II

  FDA 510(k) K823806 Active Cleared 14 Jan 1983

• Chloride Reagent

  Class II

  FDA 510(k) K781460 Active Cleared 10 Oct 1978

• Glucose Determ. Kit

  Class II

  FDA 510(k) K781307 Active Cleared 31 Aug 1978

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